Magnetic marker monitoring (MMM) study with gel matrix tablets under fasting and fed conditions - MMM
Study identifier:D1840M00017
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Characterisation of gastrointestinal transit of four new developed gel matrix tablets with different erosion rates by means of MMM measurement under fasting and fed conditions
Medical condition
Magnetic Marker Monitoring
Phase
Phase 1
Healthy volunteers
Yes
Study drug
D1000078, D1000082, D1000083, D1000085
Sex
Male
Actual Enrollment
5
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Oct 2010
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010
Study design
Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition | Drug: D1000078 Oral, one single dose |
| Experimental: 2 D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition | Drug: D1000082 Oral, one single dose |
| Experimental: 3 D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition | Drug: D1000083 Oral, one single dose |
| Experimental: 4 D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition | Drug: D1000085 Oral, one single dose |
| Experimental: 5 D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition | Drug: D1000083 Oral, one single dose |
| Experimental: 6 D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition | Drug: D1000085 Oral, one single dose |
Contacts
Investigators
Principal Investigator
Frank Donath
Socra Tec R&D GmbH, Clinical Pharmacology Unit
